Managing anticoagulation in patients with benign prostatic hyperplasia undergoing laser surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of maintaining or discontinuing oral anticoagulation (OAC) in patients undergoing photovaporization of the prostate (PVP) for benign prostatic hyperplasia (BPH). It is a multicentric, open-label, non-inferiority trial with two parallel arms, comparing outcomes between patients who continue OAC and those who stop it before surgery. The goal is to improve perioperative management and reduce complications associated with anticoagulation during BPH surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Prostate volume \< or = 30 gr
* Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...)
* Patient candidate for photovaporization of the prostate
* Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months
* Unprotected major
* Patient affiliated to a social security scheme or equivalent
* Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form.

Exclusion Criteria:

* History of prostate cancer
* Previous pelvic radiotherapy
* History of stenosis of the urethra
* Patient with one or more bladder polyps
* Patient under antiplatelet agent other than aspirin
* Allergy to heparin or history of heparin-induced thrombocytopenia
* Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux)
* Any mechanical prosthetic heart valve
* Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks
* Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks
* Major bleeding within past 6 weeks
* Severe renal insufficiency (calculated creatinine clearance \< 30 mL / min)
* Thrombocytopenia (platelet count \< 100 x 10\^9 / L)
* Life expectancy \< 1 month
* Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility)
* Contra-indication to PVP surgery or contra-indication to general anesthesia
* Protected patients : majors under some form of guardianship
* Patient participating in another clinical study

Where it's running

• Clinique Pasteur
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Vincent Misrai, Dr — Clinique Pasteur
• Study coordinator: Vincent Misraï, Dr
• Email: vmisrai@clinique-pasteur.com
• Phone: 05 62 21 33 26

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.